BEUDAMED
    4 results · 49ms · Sources: EU EUDAMED, US FDA

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    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    FDA Enforcement
    Class III ·Ongoing·AMS Diagnostics, LLC·July 19, 2017

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014

    AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014

    AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014